Division of Trauma and General Surgery, Department of Surgery, University of Pittsburgh, 200 Lothrop St, Pittsburgh, PA, 15213, USA.
Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
BMC Emerg Med. 2020 Oct 1;20(1):76. doi: 10.1186/s12873-020-00371-6.
With increased focus on early resuscitation methods following injury to improve patient outcomes, studies are employing exception from informed consent (EFIC) enrollment. Few studies have assessed patients' opinions following participation in an EFIC study, and none have been conducted within the realm of traumatic hemorrhage. We surveyed those patients and surrogates previously enrolled in the Prehospital Air Medical Plasma (PAMPer) Trial to clarify their opinions related to consent and emergency research.
Telephone calls were made between January-June 2019 to all patients who were enrolled under EFIC in the PAMPer study at the Pittsburgh site (169 of the 501 total patients enrolled, May 2014-Oct 2017) and their surrogates. Questions gauging approval of EFIC enrollment were asked before discussion of PAMPer trial outcomes, after disclosure of positive outcomes, and after a hypothetical negative trial outcome was proposed.
Of the total 647 telephone calls made, ninety-three interviews, reflecting 70 of 169 patient enrollments, were conducted. This included 13 in which only the patient was interviewed, 23 in which the patient and a surrogate were interviewed, and 34 in which only a surrogate was interviewed. Nearly half (48.4%) of respondents did not recall their personal or family member enrollment in the study. No patients or surrogates recalled hearing about the study through community consultation or being aware of opt out procedures. Patients and surrogates were glad they were enrolled (90.3%), agreed with EFIC use for their personal enrollment (88.17%), and agreed with the general use of EFIC for the PAMPer study (81.7%). Disclosure of the true positive PAMPer study outcome resulted in a significant increase in opinions regarding personal enrollment, EFIC for personal enrollment, and EFIC for general enrollment (all p < 0.001). Disclosure of a hypothetical neutral or negative study outcome resulted in significant decreases in opinions regarding EFIC for personal enrollment (p = 0.003) and EFIC for general enrollment (p < 0.001).
Clinical trial participants with traumatic hemorrhagic shock enrolled with EFIC, and surrogates of such participants, are generally accepting of EFIC. The results of the trial in which EFIC was utilized significantly affected patient and surrogate agreement with personal and general EFIC enrollment.
随着人们越来越关注创伤后早期复苏方法以改善患者预后，研究开始采用豁免知情同意（EFIC）入组。很少有研究评估过参与 EFIC 研究的患者的意见，且这些研究都未在创伤性出血领域开展。我们对先前在匹兹堡站点参与 Prehospital Air Medical Plasma（PAMPer）试验的 EFIC 入组患者和其代理人进行了调查，以明确他们对知情同意和紧急研究的相关意见。
2019 年 1 月至 6 月，我们对所有在 PAMPer 研究中根据 EFIC 入组的患者（501 名总入组患者中的 169 名，2014 年 5 月至 2017 年 10 月）及其代理人进行了电话访谈。在讨论 PAMPer 试验结果之前、披露阳性结果之后以及提出假设性阴性试验结果之后，我们提出了评估 EFIC 入组的问题。
在总共拨打的 647 个电话中，有 93 个访谈，反映了 169 个患者入组中的 70 个。其中包括 13 个仅对患者进行的访谈、23 个对患者和代理人进行的访谈，以及 34 个仅对代理人进行的访谈。近一半（48.4%）的受访者不记得他们个人或家庭成员参加了这项研究。没有患者或代理人表示他们是通过社区咨询听说过这项研究，也不知道选择退出的程序。患者和代理人对他们的入组表示很高兴（90.3%），同意为他们的个人入组使用 EFIC（88.17%），并同意为 PAMPer 研究一般使用 EFIC（81.7%）。披露真实阳性的 PAMPer 研究结果显著增加了个人入组、EFIC 用于个人入组以及 EFIC 用于一般入组的意见（所有 p 值均<0.001）。披露假设性中性或负面的研究结果显著降低了对个人入组的 EFIC 以及对一般入组的 EFIC 的意见（p 值均=0.003）。
有创伤性出血性休克的临床试验参与者及其代理人一般都接受 EFIC。使用 EFIC 的试验结果显著影响了患者和代理人对个人和一般 EFIC 入组的同意。
